FDA.reportPublic FDA data

Capsaicin 0.1 Percent

Product NDC
50488-1060
11-digit product format
504881060
Labeler code
50488
Product ID
50488-1060_4dd9a4a8-6316-41d9-b9cc-75b31e9a0fb7
Type
HUMAN OTC DRUG
Nonproprietary name
Capsaicin
Dosage form
CREAM
Route
TOPICAL
Labeler
Alexso, Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-01
Substance
CAPSAICIN
Active strength
.1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Capsaicin 0.1 Percent
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
646333Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0090ca38-6433-45c4-9453-edf2788c14c6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-1060-6Capsaicin 0.1 Percent60 g in 1 BOTTLECREAM603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1060-6GM - Gram50488-106038c057db-e25e-4398-91c3-c254eaaaf44612020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1060CAPSAICIN 0.1 PERCENT (CAPSAICIN) CREAM [ALEXSO, INC]3Current NDC, Legacy NDC, 1 package rows20241208_0090ca38-6433-45c4-9453-edf2788c14c6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 28 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOGUARDLIDOCAINE 4%ViolaCare, Inc.d8b021b6-cf71-4f7e-9d27-92d0982bd34f2026-03-25WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.4dda6ac4-d849-69a6-e063-6394a90a3c542026-03-25WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a33f9a9-1fdc-7cdf-e063-6294a90adca12026-03-25WarningsExact identifier
application number: M017
EjaGuardLIDOCAINEMOLANSPACE INC475f64ef-d636-7e87-e063-6294a90ae32f2026-03-25WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4e53d29c-ed3c-f481-e063-6294a90a31812026-03-25WarningsExact identifier
application number: M017
Topicaine UltraTOPICAINE ULTRAOncora Pharma, LLCe052f718-700a-44e0-8770-65451b812ee12026-03-24WarningsExact identifier
application number: M017
Hot Pap CataplasmaMETHYL SALICYLATE, VANILLYL NONYLAMIDEMasaem Company4dbeda13-b198-0cf0-e063-6294a90a81802026-03-24WarningsExact identifier
application number: M017
Barmicil Anti-itchHYDROCORTISONEOPMX LLC850084c3-1dd4-eb8d-e053-2a91aa0a130b2026-03-24WarningsExact identifier
application number: M017
Jeil Hangbang Paff Soo S CataplasmaGLYCOL SALICYLATE, L-MENTHOLMasaem Company4dd040db-07cf-361a-e063-6394a90a80012026-03-24WarningsExact identifier
application number: M017
Zenol Double ActionMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4da998fc-75a3-583f-e063-6394a90a59c72026-03-23WarningsExact identifier
application number: M017
Ultra Strength Topical Pain Relief CreamCAMPHOR, MENTHOL, METHYL SALICYLATEJ C UDEOZOR & SONS GLOBAL INDUSTRIES LTD4db9ae57-4ab4-8fe4-e063-6394a90a7e512026-03-23WarningsExact identifier
application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ONALIVIO TOTAL ROLL ONEVI LABS4da01338-8739-08a8-e063-6294a90ae1572026-03-22WarningsExact identifier
application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTALALIVIO TOTALEVI LABS4da1c3b8-9af2-6e9f-e063-6394a90a86ae2026-03-22WarningsExact identifier
application number: M017
SORE NO MOREMENTHOL CAMPHORSOMBRA COSMETICS INC.80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd2026-03-20WarningsExact identifier
application number: M017
CVS Health Antiseptic Wound WashLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy53ac017a-eccb-3b24-e054-00144ff88e882026-03-20WarningsExact identifier
application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%ANTI ITCH GELWalgreens3d6e8c62-2fcc-51c2-e063-6394a90a33f72026-03-20WarningsExact identifier
application number: M017
ANIXIKE NumbingMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5c52d7-8e81-b62f-e063-6394a90ad03e2026-03-19WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d47e8c7-d293-bf63-e063-6294a90a5fd92026-03-18WarningsExact identifier
application number: M017
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCf7aa9330-c47c-4d2f-b784-11b831d919d62026-03-18WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack99726aa3-3b45-4175-8471-279419af54572026-03-18WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
646333capsaicin 0.1 % Topical CreamPSN0090ca38-6433-45c4-9453-edf2788c14c63
646333capsaicin 1 MG/ML Topical CreamSCD0090ca38-6433-45c4-9453-edf2788c14c63
646333capsaicin 0.1 % Topical CreamSY0090ca38-6433-45c4-9453-edf2788c14c63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50488-1060-65048810600660 g in 1 BOTTLE (50488-1060-6) 60 g2020-02-010000-00-00NoNoCurrent